Class II Recall

Zydus Pharmaceuticals (USA) Inc

Product
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Classification
Class II
Status
Ongoing
Lot
Lot#: E409308, Exp 12/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Zydus Pharmaceuticals (USA) Inc — Class II Recall | MedicineWatch US